Juvenescence-backed biotech targets ‘continuous dopaminergic stimulation’ to reduce the severity of motor complications in Parkinson’s.
US biotech Serina Therapeutics has received clearance from the FDA to begin human trials of its long-acting apomorphine therapy designed for people with advanced Parkinson’s disease. The approval of the company’s investigational new drug application opens the door for a planned Phase 1b registrational study evaluating the treatment in patients whose symptoms are no longer adequately controlled with standard therapies. While a timeframe to the trial’s commencement was not provided, Serina revealed it is moving ahead with site start-up and regulatory work in Australia as part of a broader global development strategy.
The company’s lead program, SER-252, is built around the concept of continuous dopaminergic stimulation. The current gold standard for Parkinson’s treatment is oral levodopa combined with carbidopa, an approach that works well early on but leads to problems over time. Because levodopa is short-acting, dopamine levels rise and fall throughout the day, contributing to involuntary movements, motor fluctuations and increasing periods when medications stop working altogether.
Continuous dopaminergic stimulation aims to smooth out those peaks and troughs by keeping dopamine signaling more stable. Existing approaches rely on continuous infusions delivered through pumps and tubing worn most of the day, which are associated with local skin reactions that can limit long-term use. However, Serina’s approach is to reengineer how apomorphine, a well-known dopamine agonist, is delivered.
Apomorphine has long been approved in the US as a rescue therapy for sudden “off” episodes, but its short half-life and injection-site issues have kept it from broader use as a preventive treatment. SER-252 is designed to extend and stabilize apomorphine exposure through twice-weekly subcutaneous dosing, with the goal of keeping patients in a therapeutic range for longer periods without the need for continuous infusion.
The extended delivery is enabled by Serina’s proprietary platform, which uses a synthetic, water-soluble polymer called poly(2-oxazoline). The polymer is engineered to carry a predictable amount of drug and release it at a controlled rate after injection. The idea is to take molecules that are already effective but limited by rapid clearance or side effects and redesign their pharmacokinetics so they behave more consistently in the body. According to the company, its preclinical work suggests SER-252 can deliver continuous dopaminergic stimulation without the skin reactions that have plagued other apomorphine formulations.
Beyond SER-252, the company sees its approach as broadly applicable across small molecules, RNA-based therapeutics and antibody-drug conjugates, and is pursuing partnerships and licensing deals to expand its reach, having already secured a non-exclusive license with Pfizer to explore use of POZ polymers in lipid nanoparticle drug delivery.
Serina is a company with strong longevity links. Last year, the company raised new capital to advance SER-252 into the clinic, following a merger with longevity biotech AgeX Therapeutics, leading to its public listing on the NYSE American exhange. Juvenescence, a major player in the longevity biotech space, is reported to be Serina’s largest shareholder.
